Revolade

Revolade Dosage/Direction for Use

Manufacturer:

Novartis Healthcare

Distributor:

Zuellig
Full Prescribing Info
Dosage/Direction for Use
Revolade dosing regimens must be individualized based on the patient's platelet counts.
Use the lowest effective dosing regimen to maintain platelet counts, as clinically indicated.
In most patients, measurable elevations in platelet count take 1-2 weeks (see Clinical Studies under Actions).
Adults: Recommended Starting Dose: 50 mg once daily.
Monitoring and Dose Adjustment: After initiating Revolade, adjust the dose to achieve and maintain a platelet count of ≥50,000/microliter as necessary to reduce the risk for bleeding. Do not exceed a dose of 75 mg daily.
Clinical hematology and liver function tests should be monitored regularly throughout therapy with Revolade and the dose regimen modified based on platelet counts as outlined in the following text. During therapy with Revolade, complete blood counts (CBCs), including platelet count and peripheral blood smears, should be assessed weekly until a stable platelet count (≥50,000/microliter for at least 4 weeks) has been achieved. Complete blood counts including platelet counts and peripheral blood smears should be obtained monthly thereafter.
The lowest effective dosing regimen to maintain platelet counts should be used as clinically indicated.
Dose Adjustments of Revolade: Platelet Count: <50,000/microliter. Dose Adjustment or Response: Increase daily dose by 25 mg to a maximum of 75 mg/day following at least 2 weeks of therapy.
≥200,000-≤400,000/microliter: Decrease the daily dose by 25 mg. Wait 2 weeks to assess the effects of this and any subsequent dose adjustments.
>400,000/microliter: Stop Revolade; increase the frequency of platelet monitoring to twice weekly. Once the platelet count is <150,000/microliter, reinitiate therapy at a lower daily dose.
After any Revolade dose adjustment, platelet counts should be monitored at least weekly for 2-3 weeks. Wait for at least 2 weeks to see the effect of any dose adjustment on the patient's platelet response prior to considering another dose adjustment.
The standard Revolade dose adjustment, either decrease or increase, would be 25 mg once daily. However, in a few patients, a combination of different tablet strengths on different days may be required.
East Asian Patients: Revolade should be initiated at a reduced dose of 25 mg once daily for patients of East Asian ancestry (eg, Chinese, Japanese, Taiwanese or Korean) (see Pharmacokinetics: Special Patient Populations under Actions). Patient platelet count should continue to be monitored and the standard criteria for further dose modification followed.
Hepatic Impairment: Initiate 25 mg once daily (see Pharmacokinetics: Special Patient Populations under Actions).
Discontinuation of Treatment: Revolade should be discontinued if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks of Revolade therapy at 75 mg once daily.
Administration: Revolade should be taken at least 4 hrs before or after any products eg, antacids, dairy products or mineral supplements containing polyvalent cations (eg, aluminium, calcium, iron, magnesium, selenium and zinc) (see Pharmacokinetics: Absorption under Actions and Interactions).
Revolade may be taken with food containing little (<50 mg) or preferably no calcium (see Pharmacokinetics under Actions and Interactions).
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